Those readers who believe that agency regulatory cycles are determined by election cycles have a point in the short run–but not the long run. Agencies who are funded “off budget” through levies on the regulated industry have life cycles of their own. Consider the following research projects to be undertaken by the FDA. The FDA should advise all recipients of federal funds that the FDA can not use the results of the studies unless they are compliant with the Data Quality Act. CRE has under consideration a program to ensure that the resultant studies are DQA compliant.
FDA Website
Funding Opportunities
Below are funding opportunities currently accepting applications:
- Tobacco Control Regulatory Research – R211The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
- Tobacco Control Regulatory Research – R01
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The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. - Tobacco Control Regulatory Research – R033The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical and behavioral research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds made available through CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
- Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act4This Funding Opportunity Announcement (FOA) invites applications for Tobacco Centers of Regulatory Science (TCORS) using the P50 mechanism. The TCORS program objective is to conduct programs of multidisciplinary research that will inform tobacco product regulation and address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data needed to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
- Study to Measure the Subjective, Physiological and Puff Topography Measures and Perception of Flavored Little Cigars5Data on flavored cigars will be critical to the Tobacco Products Scientific Advisory Committee in studying and reporting on their public health impact. FDA is interested in this data for understanding the risks to children and adolescents, how the risks of using these products are perceived by smokers and non-smokers, and how use of these products affects health. Such research may include, but is not limited to, the following topics:
• puff topography
• physiological measures
• subjective measures
• exploring perceptionsExperimental study: Conduct an experimental study to measure the subjective, physiological and puff topography measures, and perceptions, of flavored little cigars.
- Research and analysis of clinical pharmacology of tobacco products6The primary function of the Food and Drug Administration (“FDA” hereinafter) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA’s Center for Tobacco Products (“CTP” hereinafter); implements PL 111-31 and H.R. 1256, Family Smoking Prevention and Tobacco Control Act, which was signed into law on June 22, 2009. The Contractor will provide scientific support necessary to assist in the implementation of this law under the Federal Food, Drug, and Cosmetic Act. Specifically, the contractor will assist FDA by evaluating the pharmacologic properties and safety of tobacco products. The manufacturers of some of these products (dissolvable tobacco products, cigarillos, e-cigarette etc.) have direct or implied claims that their health risks are less than those of traditional cigarettes. These potentially modified risk tobacco products (MRTPs) have been on the market for too short a time for assessment of the validity of these claims. Since the tobacco products are not regulated as drugs, their pharmacologic and harmful effects have not been evaluated by FDA.
The primary objectives of this IDIQ contract are to evaluate the pharmacokinetics and pharmacodynamics of nicotine, its metabolites, as well as tobacco specific toxic compounds after the administration of tobacco products.
In order to fulfill these tasks, the Government is proposing to perform a series of clinical pharmacology studies. For each task, the contractor shall screen and select participants, administer the tobacco products, collect data and perform data analyses, which includes but is not limited to, subject evaluation, laboratory tests, computer-assisted-self¬administered interviewing, specimen collection, assay of the specified compounds in human blood and urine, non¬ compartmental pharmacokinetic and pharmacodynamics data analyses. Data collected under this mechanism will inform FDA on the nature and the impact of the use of tobacco products on the public health which will have an impact on policies and regulations with respect to the tobacco products, as well as risk communications regarding the use of tobacco products.
- Centers of Excellence for Research Relevant to the Family Smoking Prevention and Tobacco Control Act7The National Institutes of Health intends to publish in Spring 2012 a funding opportunity to establish Centers for tobacco regulatory science. The Centers will conduct programs of multidisciplinary research that will aid the development and evaluation of tobacco product regulations, addressing research priorities [link to research priorities page] related to FDA’s Center for Tobacco Products regulatory authority.
Estimated Application Deadline: Fall 2012
- FDA Small Scientific Conference Grant Program (R13)8
- Read about CTP’s Small Scientific Conference Grant Program Priorities9FDA recognizes the value of supporting high quality, small scientific conferences. A small scientific conference is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern impacting the public’s health within the scope of the FDA’s mission.
Application Deadline: applications accepted on a quarterly basis.